'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
With regulatory uncertainties clouding the future of online pharmacies, deals in the space are showing signs of slowdown, as also fresh investment from private-equity (PE) firms and venture capitalists (VCs). The data from Venture Intelligence shows so far in 2023 (as of June 13) there has been one deal with PE-VC funding. In 2022 there were four, a sharp fall from the 12, totalling $1,520 million, the sector had attracted in 2021.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi high court order dated December 12, 2018, which prohibits online sales of medicines without a licence.
Written informed consent of each patient is required before the use of this drug, he said
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
"We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. "It (rumours of impotency) is complete nonsense," V G Somani, Drug Controller General of India said.
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
The global trials were halted after a study participant suffered a 'potentially unexplained illness, reports Sohini Das.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
The NTAGI has also stated that those having laboratory test proven SARS-CoV-2 illness should defer COVID-19 vaccination for six months after recovery, the sources said.
In a video issued by the Health Ministry, Dr Randeep Guleria, Director of the All India Institute of Medical Sciences (AIIMS) answered commonly asked questions regarding the dosage of the vaccine saying that two doses of the vaccine will have to be taken 28 days apart and protective levels of antibodies generally would develop two weeks after the second dose.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
As India holds its breath for the Covid vaccination to be begin, Sudhir Bisht provides a quick checklist of what you must know about the vaccines that will be administered to citizens.
Of the 23.9 million vaccinators who provide vaccination under the universal immunisation programme, 15.4 million will be used for Covid vaccination.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
'We must not compromise with the standard, the quality. We don't need to be the first to launch a drug but what we need is a Made in India vaccine that the entire world can rely on'
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